Remdesivir Injection
Remdesivir (Veklury) was the first drug approved by the FDA for treating the SARS-CoV-2 virus. It is indicated for treatment of COVID-19 disease in hospitalized adults and children aged 12 years and older who weigh at least 40 kg. The broad-spectrum antiviral is a nucleotide analog prodrug. [21] Full approval was preceded by the US FDA issuing an EUA (emergency use authorization) on May 1, 2020 to allow prescribing remdesivir for severe COVID-19 (confirmed or suspected) in hospitalized adults and children. [155] Upon approval of remdesivir in adults and adolescents, the EUA was updated to maintain the ability for prescribers to treat pediatric patients weighing 3.5 kg to less than 40 kg or children younger than 12 years who weigh at least 3.5 kg. [22]
The remdesivir EUA was expanded to include moderate disease August 28, 2020. This expands the previous authorization to treat all hospitalized patients with COVID-19 regardless of oxygen status